FDA notes shortage of ADHD medicines

According to the U.S. Food and Drug Administration (FDA) drugs to treat attention deficit hyperactivity disorder (ADHD) are in such short supply that hundreds of patients complain daily to the agency that they are unable to find a pharmacy with enough pills to fill their prescriptions.

This shortfall could be due to the troubled partnership between drug manufacturers and the Drug Enforcement Administration (DEA), with companies trying to maximize their profits and drug enforcement agents trying to minimize abuse by people, many of them college students, who use the medications to get high or to stay up all night. The sufferers are millions of children and adults who rely on the pills to help them stay focused and calm.

The shortage comes to light as President Obama ordered the FDA to broaden reporting of potential shortages of certain prescription drugs and to further expedite regulatory reviews that can help prevent or respond to shortages. Under the President’s order, FDA will also work with to the Department of Justice, which will examine whether potential shortages have led to illegal price gouging or stockpiling of life-saving medications.

“The shortage of prescription drugs drives up costs, leaves consumers vulnerable to price gouging and threatens our health and safety,” said Mr. Obama in a statement earlier this year. “This is a problem we can’t wait to fix. That’s why today, I am directing my administration to take steps to protect consumers from drug shortages, and I’m committed to working with Congress and industry to keep tackling this problem going forward.”

While the Food and Drug Administration monitors the safety and supply of the drugs, which are sold both as generics and under brand names like Ritalin and Adderall, the Drug Enforcement Administration sets manufacturing quotas that are designed to control supplies and prevent abuse. Every year, the DEA accepts applications from manufacturers to make the drugs, analyzes how much was sold the previous year and then allots portions of the expected demand to various companies.

Now FDA has included these pills on its official shortages list, as has the American Society of Health-System Pharmacists, which tracks the problem for hospitals. And the American Academy of Child and Adolescent Psychiatry has told the more than 8,000 doctors in its membership that shortages seem to be “widespread across a number of states” and are “devastating” for children. The FDA officials say the shortages are a result of overly strict quotas set by the Drug Enforcement Administration, which, for its part, questions whether there really are shortages or whether manufacturers are simply choosing to make more of the expensive pills than the generics, creating supply and demand imbalances.

“We have reached out to the DEA and told them that there are shortage issues,” said Valerie Jensen, associate director of the FDA’s drug shortage program. “But the quota issues are outside of our area of responsibility.”

Still, Special Agent Gary Boggs of the Drug Enforcement Administration’s Office of Diversion Control, said in an interview, “We believe there is plenty of supply.” Some high-priced pills are indeed readily available, and DEA officials said that so long as that is the case, they believe that ADHD drug supplies are adequate. Agent Boggs attributed any supply disruptions to decisions made by manufacturers.

The DEA says recent shortages were not caused by an insufficient quota but by marketing decisions taken by the companies. “Any shortage of these products is therefore a result of decisions made by industry regarding manufacturing or distribution,” Barbara Carreno, a DEA spokeswoman said, though she declined to specify those decisions. She noted that there are currently more than 200 drugs in short supply in the United States, most of which do not contain controlled substances and have nothing to do with the DEA. “There is no reason to think that the same market forces that are causing those shortages are not playing a part in these,” Carreno said.

The DEA controls roughly 400 basic substances, in addition to derivative products such as salts and ethers. The chemicals are divided into five schedules. Schedule 1 drugs include illegal substances such as heroin. Scheduled II drugs, such as Adderall and other stimulants, have a medical use but a high potential for abuse. Schedule III drugs have a somewhat lower abuse potential and include the painkiller Vicodin, while Schedule IV drugs include the tranquilizers Klonopin and Ativan. Schedule V substances include cough medicines such as Robitussin.

Novartis, for instance, makes both branded and generic versions of Ritalin; Shire Pharmaceuticals does the same for Adderall XR. In both cases, the companies have ensured that supplies of branded drugs are adequate while allowing generic versions to go wanting. “We are working diligently to ensure our supply of these products meets demand, including discussions with DEA regarding our quota levels for these controlled substances,” said Kathy Bloomgarden, a spokeswoman for Novartis.

Doctors wrote 51.5 million prescriptions for ADHD drugs in 2010, with a total sales value of $7.42 billion — an increase of 83 percent from the $4.05 billion sold in 2006, according to IMS Health, a drug information company. Agent Boggs of the Drug Enforcement Administration said his agency was concerned that ADHD drug abuse was on the rise. “We see people abuse it in college and then continue to abuse it non-medically once they leave,” he said.

Since the drugs have been shown to improve concentration, and not just in people with ADHD, they have become popular among students who are seeking a study aid. And since they can impart a euphoria that users have likened to a cocaine high, the pills are sometimes ground up by people who snort them for a thrill.

Ruth Hughes, chief executive of Children and Adults with Attention Deficit Hyperactivity Disorder, a patient advocacy organization, said the drug shortages had become so acute that many patients were going untreated, increasing their risks of deadly traffic accidents and job dismissals. “The consequences of not getting treatment can be devastating,” Ms. Hughes said.

Dr. Alexander Lerman, a psychiatrist from Chappaqua, N.Y., said his patients could not simply switch from one medicine or dosage to another without consequences. And some of his patients, he said, cannot afford the branded version of the drugs. “For the first time in my career,” Dr. Lerman said, “there is this enormous and mysterious scarcity of the basic product that is proven to work.”

ADHD is one of the most common childhood disorders. An average of 9 percent of children between the ages of five and 17 are diagnosed with ADHD per year, according to the Centers for Disease Control and Prevention. Symptoms include difficulty staying focused, hyperactivity and difficulty controlling behavior. If they are not properly medicated, children with ADHD may act out and be held back in class; adolescents might engage in impulsive, risky behavior; adults are at greater risk of being fired from their jobs.

The government sees the cost of health care coverage an issue for U.S. and the real issue is the drug manufacturing companies being in contracts with our leading health insurance suppliers such as Anthem. Insurance companies get a kick back from drug manufacturing companies by allowing consumers to only purchase the name brand drugs. Therefore, even WITH a generic available, the insurance companies force the consumer to get the name brand, at higher costs, to get their kick back. If the government really wants to fix some of the health care issues, the need to address the ties between insurance providers and drug companies that most don't know about.

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